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A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome

NCT02293395 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3037

Last updated 2017-12-26

Study results available
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Summary

The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation acute coronary syndrome \[NSTE-ACS\]).

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Acetylsalicylic acid

ASA 100 mg enteric-coated tablet once daily orally.

DRUG

Rivaroxaban

Rivaroxaban 2.5 mg tablet twice daily orally.

DRUG

Clopidogrel

Clopidogrel 75 mg once daily orally.

DRUG

Ticagrelor

Ticagrelor 90 mg twice daily orally.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Duke Clinical Research Institute

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-20
Primary Completion
2016-10-14
Completion
2016-10-14

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Hungary
  • Japan
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293395 on ClinicalTrials.gov